Evidence map›Paper›PMID 27058676›Full record

ReviewPain2016

Assessment of physical function and participation in chronic pain clinical trials: IMMPACT/OMERACT recommendations.

Ann M Taylor, Kristine Phillips, Kushang V Patel, Dennis C Turk, Robert H Dworkin, Dorcas Beaton, Daniel J Clauw, Monique A M Gignac, John D Markman, David A Williams and 29 more

Open access · greenAbstract readReview
In one paragraph

Review in Pain, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 122 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
122citing papers in PubMed, 9 pooled it
19.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

122 citing papers in PubMed, 9 syntheses or guidelines pooled it, 206 citations in OpenAlex.

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  10. Do postoperative changes in physical function affect patient-reported outcomes in patients with lumbar spinal stenosis undergoing rehabilitation? A secondary analysis of a randomized controlled trial.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2026
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  15. Using a measurement type-independent metric to compare patterns of determinants between patient-reported versus performance-based physical function in hemodialysis patients.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2024
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62 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

39 authors at 20 institutions in 3 countries.

Ann M TaylorCentre for Medical Education, School of Medicine, Cardiff University, Cardiff, Wales, United Kingdom.
Kristine PhillipsDepartment of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Kushang V PatelDepartment of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA.
Dennis C TurkDepartment of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA.
Robert H DworkinDepartment of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
Dorcas BeatonDepartment of Occupational Science and Occupational Therapy, University of Toronto, ON, Canada.
Daniel J ClauwDepartment of Anesthesiology, University of Michigan, Ann Arbor, MI, USA.
Monique A M GignacInstitute for Work and Health, University of Toronto, ON, Canada.
John D MarkmanDepartment of Neurology, University of Rochester, Rochester, NY, USA.
David A WilliamsDepartment of Anesthesiology, University of Michigan, Ann Arbor, MI, USA.
Shay BujanoverDepomed, Newark, CA, USA.
Laurie B BurkeLORAGroup LLC, Royal Oak, MD, USA.
Daniel B CarrPublic Health and Community Medicine, Tufts University School of Medicine, Boston, MA, USA.
Ernest H ChoyDivision of Infection and Immunity, Cardiff University, Cardiff, Wales, United Kingdom.
Philip G ConaghanNIHR Leeds Musculoskeletal Biomedical Research Unit, University of Leeds, Leeds, United Kingdom.
Penney CowanAmerican Chronic Pain Association, Rocklin, CA, USA.
John T FarrarDepartment of Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA, USA.
Roy FreemanDepartment of Neurology, Harvard University, Cambridge, MA, USA.
Jennifer GewandterDepartment of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
Ian GilronDepartment of Anesthesiology, Queen's University, Ottawa, ON, Canada.
Veeraindar GoliDepartment of Psychiatry, Duke University Medical Center, Durham, NC, USA.
Tony D GoverClinical and Rehabilitative Medicine Research Program, United States Army Medical Research and Materiel Command.
J David HaddoxPurdue Pharma L.P., Stamford, CT, USA.
Robert D KernsDepartment of Veterans Affairs, Veteran Affairs Connecticut Healthcare System, West Haven, CT, USA.
Ernest A KopeckyCollegium Pharmaceuticals, Inc, Canton, MA, USA.
David A LeeChadds Ford, Pennsylvania, PA, USA.
Richard MalamutTeva Pharmaceuticals, North Wales, PA, USA.
Philip MeaseRheumatology Clinic Research Division, Swedish Medical Center, Seattle, WA, USA.
Bob A RappaportAnalgesic Concepts LLC, Arlington, VA, USA.
Lee S SimonSDG Consulting LLC, Cambridge, MA, USA.
Jasvinder A SinghMedical Service, Birmingham Veterans Affairs Medical Center, Birmingham, AL, USA.
Shannon M SmithDepartment of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
Vibeke StrandDivision of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA.
Peter TugwellFaculty of Medicine, the Centre for Global Health, University of Ottawa, Ottawa, ON, Canada.
Gertrude F VanhoveJazz Pharmaceuticals, Palo Alto, CA, USA.
Christin VeasleyChronic Pain Research Alliance.
Gary A WalcoDepartment of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA.
Ajay D WasanDepartment of Anesthesiology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
James WitterNational Institutes of Health, Bethesda, MD, USA.
University of Michigan–Ann Arbor · USUniversity of Rochester · USUniversity of Washington · USCardiff University · GBTufts University · USUniversity of Toronto · CAAmerican Chronic Pain AssociationCollegium Pharmaceutical (United States) · USDigital Research Alliance of CanadaDuke Medical Center · USFord Motor Company (United States) · USHarvard University · USInstitute for Work & Health · CAMayo Clinic · USNational Institutes of Health · USNIHR Leeds Musculoskeletal Biomedical Research Unit · GBPurdue Pharma (United States) · USQueen's University · CAStanford University · USTeva Pharmaceuticals (United States) · US

Funding

Combined Behavioral & Analgesic Trial for Fibromyalgia (COMBAT-FM)R01AR059102 · NIAMS · UNIVERSITY OF WASHINGTON · PI DWORKIN, ROBERT H, ROBINSON, JAMES · 2011 to 2015
$5.5M
Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) Public-Private PartnershipU01FD005936 · FDA · UNIVERSITY OF ROCHESTER · PI DWORKIN, ROBERT H · 2016 to 2020
$2.5M
Pain Mechanisms and Outcomes in OsteoarthritisK23AR060241 · NIAMS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI PHILLIPS, KRISTINE · 2011 to 2015
$670k
FDA HHS U01 FD005936NIAMS NIH HHS K23 AR060241NIAMS NIH HHS L30 AR065256NIAMS NIH HHS R01 AR059102
6 · The paper itself

Abstract

Although pain reduction is commonly the primary outcome in chronic pain clinical trials, physical functioning is also important. A challenge in designing chronic pain trials to determine efficacy and effectiveness of therapies is obtaining appropriate information about the impact of an intervention on physical function. The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) and Outcome Measures in Rheumatology (OMERACT) convened a meeting to consider assessment of physical functioning and participation in research on chronic pain. The primary purpose of this article is to synthesize evidence on the scope of physical functioning to inform work on refining physical function outcome measurement. We address issues in assessing this broad construct and provide examples of frequently used measures of relevant concepts. Investigators can assess physical functioning using patient-reported outcome (PRO), performance-based, and objective measures of activity. This article aims to provide support for the use of these measures, covering broad aspects of functioning, including work participation, social participation, and caregiver burden, which researchers should consider when designing chronic pain clinical trials. Investigators should consider the inclusion of both PROs and performance-based measures as they provide different but also important complementary information. The development and use of reliable and valid PROs and performance-based measures of physical functioning may expedite development of treatments, and standardization of these measures has the potential to facilitate comparison across studies. We provide recommendations regarding important domains to stimulate research to develop tools that are more robust, address consistency and standardization, and engage patients early in tool development.

Indexed as

Chronic PainTreatment OutcomeClinical Trials as TopicHumansOutcome Assessment, Health CarePain ManagementPain MeasurementQuality of LifeSocial Participation

Identifiers

PMID27058676
PMCPMC7453823
OpenAlexW2338379519

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.